15) Any diabetic patients on non-steady treatment with thiazolidinediones (Actos or Avandia) within past three months prior to screening 16) Patients with a history of Barrett's esophagus 17) Patients who have severe weight-related co-morbid diseases that require immediate weight loss (e.g., life-threatening sleep apnea) 18) Patients with any serious health condition not related to their weight 19) Use of another investigational agent within 30 days prior to screening 20) Patients whom the investigator or study coordinator considers to be unable or unwilling to fulfill study requirements